The Wall Street Journal has a good article showing how colchicine, a generic medication used to treat gout since the sixth century, and available for pennies a pill until a few months ago, now costs big, brand-name bucks.

What happened? Cochicine was 'grandfathered' because it was in widespread use before the FDA was founded. The FDA has offered manufacturers willing to do safety and efficacy studies a limited period of exclusivity - so URL Pharmaceuticals did studies with under 1000 patients, filed for exclusive marketing rights, and started suing the other generic makers of this medication.

This isn't the only time an old drug has been 'rebranded' and made devastatingly expensive. Thalidomide, which caused birth defects in the early 1960s, was discovered to be a good treatment for leprosy and as an "orphan drug" was reintroduced to the market priced ~$6 per pill. When thalidomide was shown to be useful for multiple myeloma, the price jumped to $30 per pill. Cost of manufacture is under a dime a pill. The manufacturer of Thalidomide, Celgene, performed a substantially more valuable service than URL- it rehabilitated an old drug that was no longer manufactured and identified new ways it could benefit patients. There is some value to the clinical trials that URL did - which established that a slightly lower dose of colchicine increased safety. It's hard to argue that the value added by this pharmaceutical company is worth almost $5 per pill for a drug in wide use and used with awfully good safety for decades.

In the US, we have a huge 'cost per unit' issue - and this is one more example of how this happens. Patent or other regulatory protection of intellectual property grants a monopoly - which requires careful regulatory oversight. In this instance, a well-meaning regulatory move to learn about the real safety of an old drug will bleed the health care system of many millions of dollars for relatively little value.